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Detailed guide: From 1 January 2021 Immunological Batch Release explainer

Veterinary Medicines Directorate

November 25
15:53 2020

Batch Protocol Review

A batch of immunological veterinary medicinal product (IVMP) cannot be placed onto the UK market without a batch release request (BRR) being submitted to the VMD.

The current guidance which provides more details on the different types of BRRs will be updated to reflect the changes described below.

For BRR you should continue to submit the relevant documentation in accordance with the guidance available on the EDQM website. Model protocols for different product types are also available on the EDQM website and these should be used.

From 1 January 2021, we will continue to recognise EU Official Batch Protocol Review (OBPR) Certificates and Official Control Authority Batch Release (OCABR) issued by an EU National Competent Authority for:

  • Products authorised in Northern Ireland via the Mutual Recognition or Decentralised procedure
  • Products authorised in Northern Ireland via the Centralised procedure
  • Existing UK wide MAs whereby the product is mutually recognised in Northern Ireland, but nationally authorised in GB and both parts of the authorisation are still subject to the same existing xxxxx/4xxx authorisation number

Placing an immunological veterinary medicinal product on the UK market

Batch Release Requests (BRRs) can only be made for IVMPs subject of an MA valid in the UK, or part of, and submitted to us in the usual way. The current fee will apply, however there will be no fee where we recognise a certificate issued by an EU National Competent Authority.

We will only issue Batch Release Certificates valid in the UK.

For BRRs submitted from 1 January 2021:

MA Type EU Cert recognition Vm number country Identifier Batch Release Certificate valid in
UK wide (national only) No Vm xxxxx/4xxx GB and NI
GB MA No Vm xxxxx/5xxx GB
NI MA (national only) No Vm xxxxx/3xxx NI
NI MA (where NI is CMS) Yes Vm xxxxx/3xxx NI
UK wide (where NI is CMS) Yes Vm xxxxx/4xxx GB and NI
CAP Yes EU MA Number NI

UK wide (where NI is CMS)

Products authorised via the Mutual Recognition or Decentralised procedures were issued with UK MAs. On 1 January 2021, your MA will continue to be valid UK wide, subject to the UK and EU operating an equivalent regulatory framework and opinions align.

Centrally Authorised Products (CAPs)

From 1 January 2021, all existing and new CAPs will only be valid in NI. Existing CAPs can be converted to GB MAs for the GB market, therefore the GB MA BRR process will apply to these.

See Application and Authorisation Process for more details on converting CAPs to GB MAs.

Special Batch Release/Out of specification

The current procedure for Special Batch Release/Out of specification will remain unchanged.

Published 25 November 2020

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